Plain English Summary

Background and study aimsHemodialysis is a process of purifying the blood of a person whose kidneys are not working normally. A condition called protein-energy wasting, where the body has decreased stores of protein and fat, is common in patients undergoing hemodialysis. Studies have looked at the benefits of oral nutritional supplements, resistance exercise (e.g., weight training) and aerobic exercise (e.g., cycling) on nutrition and physical function, but it is not known what kind of treatment is best for patients. The aim of this study is to compare the effect of oral nutritional supplementation plus resistance exercise, oral nutritional supplementation plus aerobic exercise, and oral nutritional supplementation alone.

Who can participate? Patients aged 18 to 45 undergoing hemodialysis

What does the study involve?Participants are randomly allocated to receive one of three treatments two times per week for 12 weeks: either oral nutritional supplement plus resistance exercise, oral nutritional supplement plus aerobic exercise, or oral nutritional supplement alone. At the end of the study participants’ body measurements, blood test results, physical function and quality of life are assessed.

What are the possible benefits and risks of participating?It has been shown that exercise and oral nutritional supplements are safe and beneficial. Low blood pressure and symptoms such as diarrhoea and nausea have been associated with oral nutritional supplements, but there is a lack of evidence supporting this.

Where is the study run from? Hospital General de México, Dr Eduardo Liceaga (Mexico)

When is the study starting and how long is it expected to run for? January 2016 to September 2017

Who is funding the study? Hospital General de México, Dr Eduardo Liceaga (Mexico)

Who is the main contact?1. Dr Lucía Monserrat Pérez2. Miss Geovana Martin

Study design

Primary study design

Secondary study design

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Hemodialysis

Intervention

Method of randomization: A blocked design will be used, using an online statistical computing web programming (www.randomizer.org) to generate the randomization schedule, 14 sets of 3 unique numbers per set range from 1 to 3 (representing the three treatment arms).

Aerobic exercise armPatients of this group receive the same specialized oral nutritional supplement during the HD session, half of the a can is administered during the first hour of the HD session and the other half after the AE routine. Aerobic exercise consists of pedaling a stationary bike for the first two hours of the HD session, the optimal exercise time is established during the first session, then is gradually increased to reach 20-30 minutes. The scale of perceived exertion Borg (6-20) is used to establish the intensity of the exercise (moderate intensity, 12-13).

Resistance exercise armPatients of this group receive the same specialized oral nutritional supplement during the HD session, half of the a can is administered during the first hour of the HD session and the other half after the RE routine. Patients are trained for three months according to an adaptation to the program “Exercise: A Guide for People on Dialysis”. Four types of resistance exercise are performed during the second hour of the HD session (four sets of 20 repetitions for 40 min). TheraBand Latex Resistance Bands are used to individualize the exercise. The scale of perceived exertion Borg (6-20) is used to establish the intensity of the exercise (moderate intensity, 12-13)

Frequency and duration of treatment: Two times per week for 12 weeks (40 minutes of resistance exercise and 30 minutes of aerobic exercise) Follow-up: 12 weeks